Covid19NCT04558385
Seroconversion in COVID-19 Recovered Population
An observational study of Covid19, run by Lahore General Hospital at 1 site in Pakistan.
Trial summary
This study investigate the kinetics of IgG responses to both N and S proteins in the subjects who suffered from COVID 19 and then had recovered. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- IgG SARS CoV2
- How many people
- 275 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2020to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: population who have suffered from COVID 19, whose disease was either confirmed by PCR or clinically and then recovered
Who may be able to join
- Subjects recovered from COVID 19 confirmed on PCR or clinically
Who cannot join
- subjects who have not been confirmed suffering from COVID 19 by PCR or clinically
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seroconversion in COVID-19 Recovered Population: an Observational Study
This study investigate the kinetics of IgG responses to both N and S proteins in the subjects who suffered from COVID 19 and then had recovered.
Read the detailed description
Coronaviruses (CoVs) are enveloped, single positive-strand RNA viruses belonging to the large subfamily Coronavirinae, which can infect mammals and several other animals.The continued spread of coronavirus disease 2019 (COVID-19) has prompted widespread concern around the world, and the World Health Organization (WHO), on 11 March 2020, declared COVID-19 a pandemic. Studies on severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) showed that virus-specific antibodies were detectable in 80-100% of patients at 2 weeks after symptom onset. Currently, the antibody responses against SARS-CoV-2 remain poorly understood and the clinical utility of serological testing is unclear Little is known about the kinetics, tissue distribution, cross-reactivity and neutralization antibody response in COVID-19 patients .
The seropositivity rate of both IgM and IgG responses after onset and recovery of disease, and in the context of both N protein and S protein has not been clarified. The kinetics of antibody responses in critical cases or ICU patients has not been reported, and no studies have suggested whether antibody response is associated with disease prognosis
- Conditions
- Covid19
- Being tested
- IgG SARS CoV2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgG SARS CoV2Diagnostic test
IgG SARS CoV 2 will be checked in serum of COVID 19 recovered population
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG SARS CoV2
Presence or absence of SARV CoV2 IgG antibodies
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Jul 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amina Asif, Lahore General Hospital
- Investigators
- Amina Asif, MPhilMicro, Principal investigator, LahoreGeneralHospital.Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558385
- Sponsor's protocol ID
- LGH006
- Status last verified
- Mar 2021
- First submitted
- 20 Sep 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroconversion in COVID-19 Recovered Population: an Observational Study
- ClinicalTrials.gov ID
- NCT04558385
- Acronym / sponsor ID
- LGH006
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigate the kinetics of IgG responses to both N and S proteins in the subjects who suffered from COVID 19 and then had recovered.
Detailed description
Coronaviruses (CoVs) are enveloped, single positive-strand RNA viruses belonging to the large subfamily Coronavirinae, which can infect mammals and several other animals.The continued spread of coronavirus disease 2019 (COVID-19) has prompted widespread concern around the world, and the World Health Organization (WHO), on 11 March 2020, declared COVID-19 a pandemic. Studies on severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) showed that virus-specific antibodies were detectable in 80-100% of patients at 2 weeks after symptom onset. Currently, the antibody responses against SARS-CoV-2 remain poorly understood and the clinical utility of serological testing is unclear Little is known about the kinetics, tissue distribution, cross-reactivity and neutralization antibody response in COVID-19 patients .
The seropositivity rate of both IgM and IgG responses after onset and recovery of disease, and in the context of both N protein and S protein has not been clarified. The kinetics of antibody responses in critical cases or ICU patients has not been reported, and no studies have suggested whether antibody response is associated with disease prognosis
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- population who have suffered from COVID 19, whose disease was either confirmed by PCR or clinically and then recovered
Key inclusion criteria (1 listed)
- Subjects recovered from COVID 19 confirmed on PCR or clinically
Key exclusion criteria (1 listed)
- subjects who have not been confirmed suffering from COVID 19 by PCR or clinically
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IgG SARS CoV2IgG SARS CoV 2 will be checked in serum of COVID 19 recovered population | Diagnostic test | – |
Primary outcome
IgG SARS CoV2
Time frame: 5 months
Presence or absence of SARV CoV2 IgG antibodies
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amina Asif, MPhilMicro principal investigator
LahoreGeneralHospital.Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Lahore General Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IgG SARS CoV2 (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.